FDA.reportPublic FDA data

OCCObaby

Primary DI
00863101000313
Brand
OCCObaby
Company
DEOCCO LLC
Model
OCCOscan
Device description
The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131243000NON-CONTACT INFRARED THERMOMETERShenzhen Jumper Medical Equipment Co., Ltd.2013-11-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863101000313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863101000313008631010003138631010003130863101000313

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080378236
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016971104OCCObabyOCCOflex 43DT-F10S-43332020-10-21
00863101000306OCCObabyOCCOflexDT-F10S-43202016-09-23
00863101000320OCCObabyOCCOscan OCCOflex Bundle2016-09-23

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Primary DI, Brand, Company table
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22